An observational study in Menorrhagia Due to Benign Causes, sponsored by University Hospital Southampton NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by University Hospital Southampton NHS Foundation Trust · Observational
Heavy menstrual bleeding (HMB) affects 1 in 3 women and can significantly impact quality of life. Despite its prevalence, there is no accessible and accurate diagnostic test. This research will use wearable sensors, magnetic resonance imaging (MRI) scans, and biological sample collection to identify changes in the uterus linked with HMB. The investigators aim to recruit approximately 130 participants across two study sites over three years, including people with and without HMB.
Heavy menstrual bleeding (HMB) affects up to one-third of women of reproductive age, with a greater prevalence than asthma or diabetes, yet it remains under-recognised and undertreated. HMB is both a symptom and a potential signal of underlying reproductive or systemic dysfunction, including coagulopathies, vascular fragility, inflammation, and abnormal uterine contractility. Its impact is profound, physically, emotionally, and socioeconomically, but current diagnostic practice relies heavily on subjective reporting.
Objective assessment of blood loss is possible with the alkaline haematin test, the gold standard, but it is rarely used in clinical settings due to logistical barriers. This has led to misclassification in research and clinical care, limiting progress in understanding the mechanisms of HMB. Emerging evidence suggests that subtle abnormalities in uterine peristalsis, endometrial repair, and tissue composition may be detectable with advanced imaging and electrophysiology.
The REPAIR study addresses this by integrating anatomical (MRI), functional (wearable electrophysiology), and biological (biosample analysis) measures in women with and without objectively confirmed HMB. This approach aims to establish reproducible physiological signatures that could form the basis of scalable, non-invasive diagnostics.
Participants will be recruited from in and around Hampshire with the ability to attend Southampton General Hospital for appointments. They will be recruited from both within hospital settings but also the community as many women suffer with HMB without seeking support.
Exclusion Criteria:
diagnosed heavy periods with haematin test (\>/80ml)
not diagnosed as heavy with haematin test (\<80ml)
Frequency of uterine contractions (contractions per minute) measured using cine MRI (HASTE vs TRUFI sequences)
Frequency of uterine contractions quantified from cine MRI sequences and compared between participants with heavy menstrual bleeding and controls.
Time frame: Cycle 1, Days 18-21 (luteal phase; each cycle is 28 days)
Dominant frequency of uterine bioelectrical activity measured by wearable pelvic electrodes
Dominant frequency (Hz) of uterine bioelectrical signals recorded using wearable pelvic surface electrodes and analysed using frequency-domain methods.
Time frame: Cycle 1, Days 18-21 (luteal phase) and Cycle 2 Days 1-5 (menstruation) (each cycle is 28 days)
Acceptability of wearing device (usability score)
Participant-reported usability and acceptability assessed using a structured usability questionnaire developed for this study, comprising 9 items with ordinal response scales. Responses will be assigned numerical values and summed to generate a composite usability score (range 9-36, with higher scores indicating greater acceptability).
Time frame: Cycle 2, Days 1-5 (menstruation; each cycle is 28 days)
Molecular markers in endometrial biopsy sample
Quantification of molecular biomarkers in endometrial biopsy tissue using histological and molecular analysis techniques (units dependent on biomarker, e.g., pg/mg tissue).
Time frame: Cycle 1 (each cycle is 28 days), assessed at Days 1-5 (menstruation) and Days 18-21 (luteal phase)
Molecular markers in vaginal swab samples
Measurement of molecular markers from vaginal swabs using laboratory-based assays.
Time frame: Cycle 1, Days 1-5 (menstruation); Days 6-10 (post-menstruation); and Days 18-21 (luteal phase) (each cycle is 28 days)
Molecular markers in menstrual effluent
Analysis of biomarkers in menstrual effluent collected during menstruation.
Time frame: Cycle 1 (each cycle is 28 days), assessed at Days 1-3 (menstruation)
Concentration of molecular biomarkers in blood samples
Measurement of circulating biomarkers in peripheral blood samples using laboratory assays (units dependent on biomarker, e.g., pg/mL).
Time frame: Baseline
Plan to share: No
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University Hospital Southampton NHS Foundation Trust